临床试验/NCT02775526

NCT02775526已完成不适用

Trans-Obturator Tape, Tension-Free Vaginal Tape and Burch Colposuspension for Treatment of Female Mixed Urinary Incontinence: A Randomized Clinical Trial

Ain Shams University1 个研究点分布在 1 个国家目标入组 220 人开始时间: 2016年5月最近更新: 2020年1月28日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Ain Shams University
入组人数: 220
试验地点: 1
主要终点: subjective cure rate

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This prospective interventional randomized controlled trial will recruit women with MUI scheduled for surgical treatment where patients will be randomized to either Burch colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2 years. The primary outcome measures will be the objective and subjective cure rates.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

性别: Female
接受健康志愿者: 否

入选标准

•Women with mixed urinary incontinence.

排除标准

•Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study.
•Women who improved on medical treatment with persistence of stress element only were also excluded.

结局指标

主要结局

subjective cure rate

时间窗: 2 years

objective cure rate

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方

Ain Shams University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Mohamed S Sweed, MD

Ain Shams University

研究点 (1)

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